Health Ent., Inc. FDA Record
- No warning letters matched by name
Health Ent., Inc. has 0 FDA recalls, 0 inspections, 1 510(k) clearance and 0 compliance actions on record. No FDA warning letter addressed to "Health Ent., Inc." is on file.
- Latest 510(k)
- Oct 8, 2004
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 1 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 0 | Nov 15, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
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Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K041877 | ACU-STRAP MOTION SICKNESS BAND | Oct 8, 2004 |
Health Ent., Inc. and the FDA: common questions
Has Health Ent., Inc. received an FDA warning letter?
No FDA warning letter addressed to the name "Health Ent., Inc." is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has Health Ent., Inc. received an FDA Form 483?
FDA has not published a Form 483 for "Health Ent., Inc." in its reading room. FDA publishes some Form 483s, not all of them.
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